Basel, Switzerland, June 27, 2012 --(PR.com
)-- SFL is pleased to announce that Shayesteh Fürst-Ladani, Managing Director of the company, has been invited to chair a session and give a presentation at the DIA 2012 48th Annual Meeting to be held June 24–28 at the Pennsylvania Convention Center in Philadelphia, US.
Shayesteh will be chairing the session “Update on Revision of European Medical Device Directives and Impact on Industry” on Wednesday, June 27 at 1:30 PM–3:00 PM. In her opening presentation at the session, entitled “An Overview on the Revision of the EU Medical Device Directives including In-Vitro Diagnostics Directive” Shayesteh will provide an overview of the latest development and EU Commission’s proposals in these areas in comparison to the current legislation.
At the session, the audience will also obtain insight on the impact of the revised legislation on the system of third party assessment (Notified Body) in Europe and learn about the elements changed in the supervision by the third parties on industry and other stakeholders as consequence of the revised legislation. Furthermore, there will be discussion concerning the impact of the revised legislation on the company procedures and strategy as well as an overview on the current and future reporting of serious adverse events from medical device trials in Europe will be provided.
“This session will assist manufacturers in understanding the changes taking place in EU legislation for medical devices,” commented Shayesteh. “It will enable them to learn about the practical implications of these developments and understand what will be expected of them in the future in terms of meeting accepted standards.
Shayesteh is the Managing Director and founder of SFL Regulatory Affairs & Scientific Communication Ltd. She leads the team and provides global strategic support for the development of healthcare products. Shayesteh has a comprehensive knowledge base and experience in formulating global regulatory strategy for drugs, orphan drugs, drug & device combination products, borderline products, medical devices, in vitro diagnostics and advanced therapy medicinal products.
Shayesteh is Chair of Combination Products Topic Group at EuropaBio and Medical Device Working Group at EUCOPE. She has been member of the Program Committee of DIA EuroMeeting for 2011, 2012 and 2013 leading the Theme Drugs, Devices, In Vitro Diagnostics and their Combinations. Shayesteh is also Chair of SIAC (Special Interest Area Community) for Devices & Diagnostics at DIA.
About SFL Regulatory Affairs & Scientific Communication Ltd
SFL provides a holistic approach to lifecycle management of healthcare products. The company’s team of professionals have experience in Regulatory Affairs, Public Affairs, Legal Services and Medical Communications. We support our clients by offering personalized and comprehensive services. When combined, these services provide an integral oversight package for products from the bench to the marketplace at one consultancy.